CTRI/2023/06/054569已完成Unknown
Evaluation Of the Cumulative Irritation and Sensitization Potential of Test Products in Healthy Adult Human Subjects by Repeat Insult Patch Testing. - NI
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 201
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy adult male/female subjects will be considered as potential participants in the study. Subjects must be enrolled in the study only after obtaining written informed consent.
- •Subject must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
- •1) Age: 18-65 years (both inclusive) at the time of consent.
- •2) Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of
- •males and females).
- •3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •4) Subjects who do not have any previous history of adverse skin conditions and are not
- •under any medication likely to interfere with the results.
- •5) Subjects in good general health as determined by the Investigator on the basis of medical history.
- •6) Subjects willing and able to follow the study directions, to participate in the study,
- •returning for all specified visits.
- •7) Subjects must be able to understand and provide written informed consent toparticipate inthe study.
- •8) Subjects willing to refrain from vigorous physical exercise during the study period.
排除标准
- •Subjects must not be enrolled in the study if they meet any one of the following criteria:
- •1) Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation,
- •pimples, marks [e.g., tattoos (within the previous 3 months), scars, sunburn], open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the
- •test site(s) i.e., back that can interfere with the reading.
- •2) Medication which may affect skin response and/or past medical history.
- •3) Subjects having history of diabetes.
- •4) Subjects have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •5) Subjects suffering from any active clinically significant skin diseases which may
- •contraindicate.
- •6) Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •7) Subjects participating in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
- •8) Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •9) Subjects with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- •10) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
- •11) Subject with known allergy or sensitization to medical adhesives, bandages.
- •12) Subject reports a history of skin sensitivity to shampoos and detergents or a known
- •hypersensitivity and/or sensitization to medical adhesives.
- •13) Subjects reports use of systemic or topical antihistamines (at any site) or uses of
- •topical drugs at patch site(s) within 72 hours prior to patch application.
- •14) Participation in other patch study simultaneously.
- •15) Use of any:
- •i. Prescribed or over the counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •iii. Systemic or topical corticosteroids at patch site within four (4) weeks of Test Product application (steroidal nose drops and/or eye drops are permitted).
- •iv. Topical drugs used at application site.
研究者
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